MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

Model Number	9438-05
Medical Device Problem Codes	Imprecision (1307); Use of Device Problem (1670)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Dexcom was made aware on (b)(4) 2018 that on (b)(6) 2018, there was an inaccuracy between the continuous glucose monitor (cgm) and the blood glucose (bg) meter.The sensor was inserted into the abdomen on (b)(6) 2018.Reportedly, the patient used an expired sensor.No additional event or patient information is available.No data was provided for evaluation.The complaint confirmation and probable cause could not be determined.Labeling indicates: do not insert sensors past the expiration date.The expiration date format is yyyy-mm-dd.Insert sensors on or before the end of the calendar day printed on the sensor package label.The complaint device was returned for evaluation.The device was visually inspected and no defect was found.Functional testing was performed and the reported fault could not be reproduced and there was no failure detected.A voltage test was performed and it passed.The reported event of inaccuracies was not confirmed.The probable root cause cannot be determined.

• Brand Name: DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
• Common Device Name: CONTINUOUS GLUCOSE MONITOR
• Manufacturer (Section D): DEXCOM, INC.; 6340 sequence dr.; san diego CA 92121
• MDR Report Key: 7297699
• Report Number: 3004753838-2018-020136
• Device Sequence Number: 2248521
• Product Code: MDS
• UDI-Device Identifier: 40386270000048
• UDI-Public: 40386270000048
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P120005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/11/2017
• Device Model Number: 9438-05
• Device Catalogue Number: STT-RX-001
• Device Lot Number: 5211550
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2018
• Initial Report FDA Received Date: 02/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 8 YR
• Patient Weight: 24